1. Field of the Invention
The present description relates to a method and an apparatus for nondestructive testing of the integrity of bioreactor containers, and to a use of a fluid-permeable and/or structured reception sheet.
2. Description of the Related Art
In the pharmaceutical and biotechnology industries, flexible containers, for example bags, are used as bioreactor containers for processing or storage. The bioreactor containers may become damaged before actual use by the production process, transport or handling. It is therefore recommendable to carry out an integrity test of the bioreactor container before actual use. An integrity test is also expedient after use of the bioreactor container, in order to ascertain whether the integrity of the bioreactor container was maintained throughout the entire processing. The term “bioreactor container” in the context of the application therefore equally includes bioreactors and containers having locally flexible walls, which are used for example to receive, mix, store and dispense sterile media.
Conventional test methods for testing the integrity of a bioreactor container are the pressured drop method, flow measurement and trace gas analysis with the use of a test gas. A common feature of all the test methods is that a pressure difference is generated between the interior of the bioreactor container and a test apparatus containing the bioreactor container, or the surroundings of the bioreactor container. To this end, after production, or before and/or after use, the bioreactor container to be tested is arranged in a test apparatus for testing the integrity. This entails the risk that the bioreactor container to be tested will become damaged during the handling necessary for this, so that a leak is formed in the per se leaktight bioreactor container.
It is therefore an object of the invention to provide a method and an apparatus for testing the integrity of bioreactor containers, which allow improved integrity testing of the bioreactor container.